title: Microbiologic quality assurance for intravenous admixtures in a small hospital.
abstract: A simple, inexpensive method for end-product testing of intravenous admixtures for microbial contamination was developed and tested by challenging the system with low levels of microbial contamination. The 16-step procedure for testing i.v. admixtures for microbial contamination used total-sample membrane filtration A 0.2-micrometers Nalgene filter unit was used; the entire contents of randomly selected admixtures were to be filtered and discarded under the procedure. Filters were incubated on sheep-blood agar plates for 48 hours at 35 degrees C. Low concentrations (Klebsiella pneumoniae and Pseudomonas aeruginosa were used to contaminate admixtures deliberately to challenge the system. Seventy-two solutions were contaminated with each microbe; 72 other solutions were inoculated with sterile 0.9% sodium chloride; and 72 uninoculated solutions served as controls. Filtration was performed on a laboratory bench to prevent contamination of the laminar-flow hood. In deliberately contaminated solutions, a mean of 82% of inoculated organisms was isolated by membrane filtration. Five instances of adventitious contamination were noted among the 288 samples; these occurred across all experimental groups. Cost per sample was $4-5. This system can be used by hospital pharmacists to produce documentation of quality assurance that will be acceptable in terms of cost, simplicity, and accuracy.
mesh_terms: D004339:Drug Compounding / Q000592:standards*; D004340:Drug Contamination / Q000517:prevention & control*; D004349:Drug Packaging / Q000592:standards; D006764:Hospitals, Community; D007275:Injections, Intravenous; D007711:Klebsiella pneumoniae; D011550:Pseudomonas aeruginosa; D011786:Quality Control; D014462:Ultrafiltration / Q000592:standards